InvestorsHub Logo
Followers 29
Posts 451
Boards Moderated 0
Alias Born 10/04/2008

Re: horselover45 post# 121535

Wednesday, 05/08/2013 3:06:48 PM

Wednesday, May 08, 2013 3:06:48 PM

Post# of 345745
The Guidelines for EOP2 meetings require the FDA to hold the meeting within 60 days after application is made by the Company. Given that the Company was almost ready to apply for the EOP2 meeting back in Sept when things blew up, it is reasonable to assume that they applied to the FDA within days of confirming their reconstructed Phase IIb data and announcing it on Feb 19. We also know from Garnick's remarks during the March 12 CC that he was hard at work submitting the final filing package at that time.

Thus I am assuming the EOP2 meeting was held in late April or first week of May. I do not know this for a fact.

However, I am told by IR that the better practice is to wait to announce the results of the EOP2 meeting until after the Minutes of the meeting have been finalized, and according to the EOP2 Guidelines, that can take up to 30 more days after the meeting to allow for further back and forth discussion and finalization of the Minutes.

The Minutes of an EOP2 meeting, once finalized, are like a decision of a court. They are binding on the FDA and the Company. All the BPs who are looking at a possible alliance with PPHM will review and rely on the final Minutes of that meeting before committing big bucks to a partnership.

IMO we are only waiting now for the minutes to be finalized and that could happen any time in the next 3 weeks.


Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent CDMO News